U.S. Pat. Nos. 7,304,036 and 7,371,727 disclose peptides that act as agonists of the guanylate cyclase C (GC-C) receptor for the treatment of gastrointestinal disorders. One particular peptide disclosed is linaclotide, which consists of the following amino acid sequence (SEQ ID NO: 1):
The '036 and '727 patents also disclose methods for preparing linaclotide and related peptides. The contents of these patents are incorporated herein by reference in their entirety.
There remains a need for improved linaclotide compositions that have improved stability against formaldehyde, which can enter linaclotide compositions from a variety of sources.
The present invention seeks to provide such improved linaclotide compositions, as well as methods of treating gastrointestinal disorders by providing the linaclotide compositions to patients in need thereof.